CQV Downstream Lead
cagents· North Europe
About this role
CAI Overview
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About Us
CAI is a professional services company established in 1996 that has grown year over year to nearly 800 people worldwide. For Life Sciences and Mission Critical industries that need to deliver critical solutions in high-stakes environments, we provide accelerated operational readiness and unparalleled performance at the highest standard through our rigorous approach, field-tested processes, and elite expertise developed over 30 years.
About the Role
We are hiring a CQV Downstream Lead to manage commissioning and qualification activities across downstream process systems on a major biopharmaceutical manufacturing project.
This is a high-visibility leadership role where you will own downstream CQV delivery from system design review and risk assessment through execution, qualification (IQ/OQ/PQ), and handover to Operations.
Responsibilities
Lead end-to-end CQV for downstream systems (design, IQ/OQ/PQ, handover)
Own downstream technologies: chromatography, UF/DF/TFF, filtration, CIP/SIP
Drive system readiness: walkdowns, punch lists, FAT/SAT, startup
Execute risk-based CQV strategy (GMP, Annex 15, ASTM E2500)
Lead IQ/OQ/PQ execution and ensure right-first-time delivery
Oversee CQV documentation (plans, risk, protocols, reports)
Manage deviations, change control, CAPAs, inspection readiness
Coordinate across Engineering, QA, Automation, Ops, Vendors
Lead and mentor CQV team members
Requirements
Degree in Engineering, Biotechnology, or related
7+ years CQV experience in biopharma (strong downstream focus
Experience with CQV documentation, deviations, change control
Strong stakeholder and on-site leadership skills
Preferred
Experience leading CQV on large capital projects
Knowledge of downstream purification (capture, polish, viral filtration)
Exposure to single-use systems, skids, or automation interfaces
Experience supporting audits / inspections / operational readiness
What’s In It For You
Lead high-impact downstream CQV delivery on a flagship biologics project
Work with cutting-edge purification technologies and systems
Join a high-performing CQV team on complex, large-scale builds
Gain strong visibility with clients and senior project stakeholders
Exposure to end-to-end project lifecycle
Frequently Asked Questions
Is the salary disclosed for the CQV Downstream Lead position at cagents?
The salary for this CQV Downstream Lead role at cagents is not publicly listed. Click "Apply Now" to learn more about the compensation package on their official careers page.
Where is the CQV Downstream Lead position at cagents located?
This CQV Downstream Lead role at cagents is based in Limerick. The position is listed as on-site or hybrid. Check the full job description or apply directly to confirm the work arrangement.
Is the CQV Downstream Lead role at cagents full-time or part-time?
This is listed as a Full Time position. It is posted as a CQV Downstream Lead role in the North Europe department at cagents.
Which team or department does the CQV Downstream Lead at cagents belong to?
This CQV Downstream Lead position is part of the North Europe department at cagents. See the full job description for more information about the team structure and responsibilities.
How do I apply for the CQV Downstream Lead position at cagents?
Click the "Apply Now" button on this page. You will be redirected to cagents's official application portal hosted on lever where you can submit your application directly.
When was the CQV Downstream Lead job at cagents posted?
This CQV Downstream Lead position at cagents was posted on Jun 12, 2026. Apply as soon as possible — early applications are often reviewed first.
CQV Downstream Lead
cagents
You'll be redirected to cagents's official application page on Lever.